Surgical robotic access system for irregularly shaped robotic actuators and associated robotic surgical instruments

ABSTRACT

The surgical robotic access system provides access for robotic instruments and/or actuators including the introduction, operation and withdrawal of such robotic manipulators into a body cavity without permitting the escape of pressurized fluid or gas. The surgical robotic access system also provides a multi-faceted range of movement without touching or effecting pressure on the opening in the patient&#39;s body cavity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/697,288 filed Sep. 6, 2017, which claims priority to and benefit ofU.S. Provisional Application No. 62/393,305, filed on Sep. 12, 2016, theentire disclosure of which is hereby incorporated by reference as if setforth in full herein.

BACKGROUND

This application is generally directed to surgical access devices andmore particularly to surgical access systems for surgical robotics orirregularly shaped instruments.

Surgical robotics has been gaining acceptance and seeks to replace orassist in particular surgical procedures. In particular, some surgicalassistance provided by surgical robotics is designed to alleviatecomplicated or repetitive tasks. However, surgical robotics provideschallenges where procedures performed by a surgeon without roboticassistance would not encounter. One such area is with surgical accessdevices used in surgery to facilitate the introduction of varioussurgical instruments into natural biological vessels, conduits,orifices, cavities, and other interior regions of the body. Surgicalrobotic instruments or actuators impose other restrictions that are notencountered or not a limitation with other surgical instruments oractuators, e.g., a surgeon's hand. Such challenges are furtherexasperated by the limited or restricted surgical area or environment.For example, the surgical environment may require an introduction oflaparoscopic or particular sized instruments or actuators into theabdomen of the body and/or introduced into regions that include fluid orgas under pressure.

SUMMARY

In various exemplary embodiments, a surgical robotic access systemcomprises a surgical robotic access platform. The surgical roboticaccess platform comprises a sealing cap that sealingly conforms orengages with the irregularly shaped robotic manipulators and/or arobotic sheath while maintaining pneumoperitoneum during insertion,operation and removal of the robotic manipulator. In various exemplaryembodiments, the robotic sheath is removably insertable into the sealingcap. In various exemplary embodiments, the sheath is removable, e.g.,separable or can be torn, to expose the robotic manipulator or at leasta portion of the robotic manipulator and/or to remove the sheath fromthe surgical site, the robotic access platform, the robotic manipulatoror any combination thereof.

In various exemplary embodiments, a surgical robotic access systemproviding instrument access into a patient's body is provided. Thesurgical robotic access system comprises a surgical robotic accessplatform and a robotic sheath. The surgical robotic access platform hasa proximal portion disposed externally relative to a patient's body anda distal portion positioned within a patient's body in which theproximal portion of the surgical robotic access platform includes aflexible seal. The robotic sheath has a proximal end and a distal endinsertable through the flexible seal of the surgical robotic accessplatform. The robotic sheath also has an expandable cover disposed atthe distal end of the robotic sheath and defines a cavity havingproximal opening and a distal opening and through which a surgicalrobotic manipulator is insertable therethrough. In various exemplaryembodiments, the expandable cover of the robotic sheath is arranged toencase and surround a distal end of the surgical robotic manipulatorwithin the cavity of the robotic sheath and the flexible seal isarranged to encase and surround the expandable cover of the roboticsheath to compress the expandable cover of the robotic sheath againstthe distal end of the surgical robotic manipulator and thereby maintainan insufflation gas seal between the surgical robotic manipulator, therobotic sheath and the flexible seal.

In various exemplary embodiments, the sealing cap comprises a mesh ormesh lined pattern molded into a flexible seal that prevents or reducesundesired movement of the area of the flexible seal that is sealingaround the robotic manipulator and/or the robotic sheath. In variousexemplary embodiments, the flexible seal includes or is incorporatedwith a netting, mesh, webbing or interwoven strings or plastic lines tosupport or reinforce the flexible seal.

In various exemplary embodiments, the sealing cap includes a flexibleseal fortified to resist puncture or damage from irregularly shaped orsharp robotic manipulators. In various exemplary embodiments, aprotector or shield is embedded or attached to the flexible seal toprotect the flexible seal, the robotic sheath, the robotic manipulatoror any combination thereof. In various exemplary embodiments, theflexible seal includes shields or protectors such as sheets of resilientor puncture resistant film, fabric, plastic or the like within or on asurface of the flexible seal or arrayed at or near an access point orpredefined opening through the seal. In various exemplary embodiments,the sealing cap provides laparoscopic or robotic manipulator or sheath,insufflation, and/or smoke evacuation access.

These and other features of the invention will become more apparent witha discussion of exemplary embodiments in reference to the associateddrawings.

BRIEF DESCRIPTION OF DRAWINGS

The present inventions may be understood by reference to the followingdescription, taken in connection with the accompanying drawings in whichthe reference numerals designate like parts throughout the figuresthereof.

FIG. 1 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 2 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 3 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 4 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 5 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 6 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 7 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 8 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 9 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 10 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 11 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 12 is a side view of a robotic sheath of a surgical robotics accesssystem in accordance with various exemplary embodiments.

FIG. 13 is a side view of a robotic sheath of a surgical robotics accesssystem in accordance with various exemplary embodiments.

FIG. 14 is a perspective view of a robotic sheath of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 15 is a top view of a sealing cap of a surgical robotics accesssystem in accordance with various exemplary embodiments.

FIG. 16 is a top view of a sealing cap of a surgical robotics accesssystem in accordance with various exemplary embodiments.

FIG. 17 is a bottom view of portions of a sealing cap of a surgicalrobotics access system in accordance with various exemplary embodiments.

FIG. 18 is a bottom view of portions of a sealing cap of a surgicalrobotics access system in accordance with various exemplary embodiments.

FIG. 19 is a top view of a sealing cap of a surgical robotics accesssystem in accordance with various exemplary embodiments.

FIG. 20 is a perspective view of a sealing cap and protector of asurgical robotics access system in accordance with various exemplaryembodiments.

FIG. 21 is a perspective view of a portion of a sealing cap of asurgical robotics access system in accordance with various exemplaryembodiments.

FIG. 22 is a perspective view of a sealing cap of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 23 is a perspective view of a sealing cap of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 24 is a perspective view of a sealing cap and protector of asurgical robotics access system in accordance with various exemplaryembodiments.

FIG. 25 is a perspective view of a sealing cap of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 26 is a perspective view of a sealing cap of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 27 is a perspective view of a sealing cap of a surgical roboticsaccess system in accordance with various exemplary embodiments.

FIG. 28 is a side view of a robotic sheath of a surgical robotics accesssystem in accordance with various exemplary embodiments.

FIG. 29 is a cross-sectional side view of a robotic sheath and sealingcap of a surgical robotics access system in accordance with variousexemplary embodiments.

FIG. 30 is a top view of a robotic sheath and sealing cap of a surgicalrobotics access system in accordance with various exemplary embodiments.

DETAILED DESCRIPTION

In accordance with various exemplary embodiments, a surgical roboticaccess system provides access for surgical robotic manipulators thatincludes but is not limited to robotic surgical instruments, actuators,irregularly shaped surgical instruments, and/or operative portions of asurgical robotic system or accessories thereof inserted and operatingwithin a patient's body. The robotic manipulators are roboticallycontrolled by the surgical robotic system autonomously or throughassistance of a surgeon without a surgeon in direct contact orphysically grasping the surgical robotic manipulator. The surgicalrobotics access system in accordance with various exemplary embodimentsmaintains pneumoperitoneum, patient safety and/or system integrityduring installation, articulation, actuation and/or removal of therobotic manipulators.

In various exemplary embodiments, the surgical robotic access systemcomprises a robotic sheath that enables ease of device placement withoutmodifications to the robotic manipulator or a surgical robotic accessplatform. The sheath converts the robotic manipulator and in particular,the irregularly shaped robotic manipulators into a smooth and/oruniformed shape, size, surface area or any combination thereof forinsertion, manipulation and withdrawal of the robotic manipulator into apatient's body. Once the robotic manipulator is placed, in variousexemplary embodiments, the sheaths may be removed to expose the roboticmanipulator or at least a portion of the robotic manipulator.

Referring now to FIG. 1, a robotic sheath 100 has a proximal portion anda distal portion. The distal portion of the sheath is configured to beinserted directly through a wall or opening in a patient's body orsurgical access platform. In accordance with various exemplaryembodiments and described in greater detail below, e.g., in reference toFIG. 29, the surgical access platform includes a sealing cap 800removably coupled to a retractor or protector 820. The sealing cap 800comprises a flexible seal 804 that in various exemplary embodiments ismade of a flexible material such as a gel material.

The robotic sheath includes retrieval tail 104 extending proximally froman expandable cover or compartment 108 having a distal end and aproximal end. The expandable cover defines a pocket or cavity 101 and invarious exemplary embodiments, a funnel shaped cavity. The distal end ofthe cover includes an opening or aperture and the proximal end of thecover includes an opening. In various exemplary embodiments, theproximal opening is larger in diameter than the distal opening of thecover. The sheath includes an outer or exterior surface that is uniformand smooth. The sheath also includes an inner or interior surface thatis uniform and smooth.

The cover 108 is arranged to receive a robotic manipulator, e.g., arobotic surgical instrument or actuator, irregularly shaped surgicalinstrument or at least a distal portion thereof inserted into thedelimited or defined lumen or cavity 101. In various exemplaryembodiments, the cavity is also sized and shaped to retain and supportthe surgical robotic manipulator. The cover includes arcuate or curvedsides 107, 109 separated by a slit 106. The slit or slot 106 extendsfrom the distal opening to the proximal opening of the cover. The slitor separation between the curved sides allows the cover or slit toenlarge or the curved sides to spread apart to thereby accommodate awide range of robotic manipulators or surgical instruments havingvarying sizes, shapes, outlines, footprints and/or surfaces. In variousexemplary embodiments, more than one slit is provided and with variouslengths to further accommodate the contours or dimensions of theinserted manipulators. The curved sides and smooth surfaces assist inthe insertion of the sheath into the body cavity or the access platformby providing a smooth interface with minimal friction between the bodywall or access platform and the sheath. As such, irregular oraggressively formed manipulators are not in direct contact with the bodyor access platform and thus cannot damage or their potential damage tothe platform or incision site is reduced. Furthermore, the smooth innersurfaces of the cover do not damage or reduces potential damage to thecover and the inserted manipulator. As such, the sheath covers orconverts the irregularly shaped robotic manipulator disposed thereininto a uniform and smooth shape or continuous surface to ease entry andplacement of the manipulator into the body cavity.

In various exemplary embodiments, a flap 105 covers or encloses thedistal opening in the cover 108. The flap is biased or removablyattached to the distal end or tip of the cover 108. As such, the flapresists pressure or forces applied to the flap from an insertedmanipulator. Once the flaps' bias is overcome or the flap is detachedfrom the expandable cover, the inserted manipulator can then extendthrough the distal opening in the cover, unobstructed by the flap. Invarious exemplary embodiments, the flap once detached or biased opencannot be reclosed or reattached to obstruct the distal opening in thecover. The flap however remains attached to the distal end of the cover.As such, the sheath can be removed as a single monolithic structure. Invarious exemplary embodiments, the flap is flat or planar with a shapethat mirrors the distal opening of the cover and provides a common andstable level or platform for the distal most end of the distal portionof the robotic manipulator. In various exemplary embodiments, the flapis attached to the cover through a living hinge.

The cover and flap separates the robotic manipulator from the body andthe platform thereby protecting the manipulator and the patient. Assuch, the inner surface of the flap is adjacent to the distal end or tipof the robotic manipulator and the outer surface of the flap is adjacentto or exposed to the surgical site. Similarly, the inner surface of thecover is adjacent to the sides of the robotic manipulator and the outersurface of the cover is adjacent to the sides of the body wall or theaccess platform. The flap also provides a known target for the insertedinstrument including the bias or amount of force needed to open ordislodge the flap. Using this known target data, a corresponding hapticfeedback can be determined and provided by a robotic surgical system torecognize or emulate the robotic manipulator entering the body wall,platform or the engagement of the flap by the inserted roboticmanipulator.

The sheath tail 104 extends from the cover and provides access or a griparea or platform to hold or stabilize the sheath for insertion orremoval. The tail 104 as such stabilizes or supports the proximallyextending longitudinal or elongate portion of the robotic manipulator.The tail 104 also provides a separate and sizable area or region tograsp or hold to remove the sheath from the surgical site. In variousexemplary embodiments, the tail 104 is tied, coupled or otherwiseattached to the robotic manipulator or a robotic sleeve surrounding therobotic manipulator to remain attached to the robotic manipulator evenafter the manipulator is extended or inserted through the flap 105. Invarious exemplary embodiments, the tail 104 is grasped, movedlongitudinally until the cover and/or flap clears the outer surface ofthe patient's body or the access platform and then is removed from therobotic manipulator and the surgical site. As such, the roboticmanipulator can then come in direct contact with the patient or accessplatform in which the patient or access platform seals or provides aninstrument seal directly against the outer surface of the insertedrobotic manipulator. In various exemplary embodiments, the tail 104 isgrasped or otherwise fixed in place to hold or stabilize the sheathrelative to the movement or motion of the inserted robotic manipulatorand as such, as the robotic manipulator is extended distally, the sheathremains stationary being held in place by a grasper, clamp or otherrobotic or surgical instrumentation attached to or otherwise graspingthe sheath.

Referring to FIG. 2, in accordance with various exemplary embodiments, arobotic sheath 200 includes an expandable cover or enclosure 208. Thecover 208 includes a proximal opening and defines a cavity or pocket201. In the illustrated exemplary embodiment, the cover 208 includesside flap or wall 202, an opposing side flap or wall 203 and a distalwall or flap 205 that collectively define or delimit the cavity 201. Acurved slit 206 separates the side wall 202 from the distal or frontwall 205 and a similar slit separates the side wall 203 from the distalwall 205 and thereby allows the cavity defined by the cover to expandand accommodate various sized and shaped manipulators inserted therein.Also, in various exemplary embodiments, the distal wall can unfold orcurl away distally thereby allowing the distal end of the manipulator toextend through the now unobstructed distal opening in the cover 208.

In various exemplary embodiments, the cover is biased proximally toinitially resist forces or pressures from a manipulator being moveddistally but once overcome allows the distal end of the manipulator toextend there through. In various exemplary embodiments the distal wall205 is removably attached to one or more side walls, e.g., the slits areor include perforations or the walls include a portion, bridge orconnections to each other, to bias or resist the distal movement of themanipulator and the separation of the walls from each other. As such,once the bias of the distal wall is overcome or the distal wall isdetached from the side walls, the distal wall can be moved or unfoldedto provide unobstructed access through the distal opening in the sheathby an inserted instrument. In various exemplary embodiments, once thedistal wall is unfolded or detached from the side walls, the distal wallmay not be reattached or folded back to cover or obstruct the distalopening of the sheath.

Additionally, with the sheath being inserted into the access platform orthrough the body wall, the distal wall is biased proximally by theaccess platform or body wall contacting the distal wall thereby alsocounteracting any forces by the manipulator being inserted, enclosingthe cavity and protecting the distal end of the inserted roboticmanipulator.

A tail 204 extends proximally from the cover 208 to support the roboticmanipulator and provides a removal or insertion support for thedeployment of the sheath 200. The tail also includes a curved connectorportion 209 connected to the cover 208. The curved connector providesadditional lateral or radial space between the robotic manipulator andthe sheath and thus allows easier access and attachment of the roboticmanipulator to the sheath. The curved connector also spaces the tailfrom the robotic manipulator to further facilitate accessibility of theremoval or insertion area of the tail used to assist in the deploymentand/or withdrawal of the sheath and the robotic manipulator.

Referring now to FIGS. 3-6, the sheath 300 includes an expandable cover308 defining a cavity or pouch 301 therein. The cavity is arranged toaccommodate a robotic manipulator inserted or seated therein. The cover308 is a tri-fold arrangement having first and second side folds orwalls 307, 309 and a center or middle fold or wall 305. The side foldsprotect or cover the sides of the robotic manipulator inserted therein.The middle fold covers a distal opening of the cover 308. In variousexemplary embodiments the first, second and middle folds are removablyconnected to each other and in various exemplary embodiments, theremovable connection includes a release line or cord 306. In variousexemplary embodiments, proximal movement of the release line disengagesor separates the removable connection between the folds. As such, themiddle fold 305 is released and can be moved distally to uncover or notobstruct the distal opening of the cover 308. In various exemplaryembodiments, all the folds of the cover are disengaged and therebyseparating all the folds from each other and unfolding or opening thecover or cavity.

In various exemplary embodiments, the release cord or line disengagesthe middle fold from the first and second folds separating the first andsecond folds from the middle fold. The release line remains connected tothe middle fold thereby allowing the regulation of the movement of themiddle fold relative to the first and second folds. As such, movement ofthe middle fold may be restricted as the sheath is inserted and at aparticular depth or timing, the middle fold is allowed move completelyaway from the first and second folds to expose the distal end and allowunobstructed deployment of the inserted manipulator through the sheath.Movement of the middle fold may also be restricted to enlarge the cavitydefined by the folds to accommodate larger or various sized and shapedinstruments beyond the initial dimension or shape of the initial cavitydefined by the folds. However, the middle fold being restricted and inplace continues to protect the distal end of the inserted manipulatorand facilitates entry of the sheath through the access device.

In various exemplary embodiments, the release line disengages one ormore of the folds from one or more of the rest of the folds to providedifferent access or exposure of the robotic manipulator to the surgicalsite or to expand portions of the cavity as desired to accommodate aparticular robotic manipulator. In various exemplary embodiments, one ormore release lines are attached to one or more folds and in variousexemplary embodiments a release line is connected to each fold therebyallowing individual and selective operation of the folds relative toeach other and dynamically adjust the cavity and exposure of roboticmanipulator as required. In various exemplary embodiments, theconnection of the folds and the release line is a perforation such thatmovement of the release line separates portions of the middle fold alongthe perforation to releasably disengage the release line from the middlefold. In various exemplary embodiments the connection, disengagement ofthe connection or both are selectively and operationally activated toincrementally, partially or fully expand the cavity of the sheath and/orseparate or unfold the sides or walls of the sheath and/or the flap. Invarious exemplary embodiments, once separated from a wall or fold, thewalls or folds cannot be reattached and thus the sheath 300 can beremoved from the surgical site to further prevent any inadvertentobstruction, leak path or restriction at the surgical site. A tail 304extends proximally from the cover 308 to support the robotic manipulatorand provides a removal or insertion support for the deployment of thesheath 300.

Referring to FIGS. 7-11, in accordance with various exemplaryembodiments, a robotic sheath 400 includes an expandable cover 411having curved side walls 407, 409 removably connected to each otherthrough interfacing cutouts and tabs. A center wall 405 is removablyconnected to one or both of the side walls 407, 409. In variousexemplary embodiments, the center wall includes foldable or deformabletabs 408 insertable into cutouts or apertures 403 in one or more of theside walls to removably connect the center wall to one or more of theside walls. The cover defines or delimits a cavity or enclosure 401 inwhich a robotic manipulator or at least a distal portion thereof isarranged to be seated therein. In various exemplary embodiments, one ormore of the side walls includes foldable or deformable tabs insertableinto cutouts or apertures in one or more of the side walls to removablyconnect one of the side walls to the other one of the side walls. In theillustrated exemplary embodiment, the side wall 407 includes an apertureor cutout 402 and the side wall 409 includes a deformable tab 406insertable into the aperture 402 to removably connect the side walls407, 409 together.

The connection between the center and side walls, e.g., the spacingbetween walls or the spacing between the tabs and apertures of thewalls, the resilient or flexible material of the walls, or a combinationthereof allows the cavity defined by the cover to expand to accommodatevarious sized and shaped robotic manipulators inserted therein. Also invarious exemplary embodiments, the center wall can unfold or curl awaydistally thereby allowing the distal end of the instrument to extendthrough the now unobstructed distal opening in the cover. The cover isbiased proximally to resist forces or pressures from a roboticmanipulator being moved distally.

Once the bias of the center wall is overcome or the center wall isdetached from one of the side walls, the center wall can be moved orunfolded to provide unobstructed access through the distal opening inthe sheath by an inserted robotic manipulator. In various exemplaryembodiments once the center wall is unfolded or detached from one of theside walls, the center wall may not be reattached or folded back tocover or obstruct the distal opening of the sheath. In various exemplaryembodiments, the deformable or frangible tabs or apertures aredisengaged or torn from each other to unfold or detach the sheath fromthe robotic manipulator. As shown in FIG. 9, only the center wall may beoperationally detached from one or both of the side walls to provideunobstructed access through the opening in the sheath. With the sidewalls attached to each other, however, the sheath can remain connectedto the robotic manipulator to further protect the manipulator or patientduring operation and withdrawal of the manipulator. As illustrated inFIGS. 10-11, all the folds or wall may be detached from each other to,for example, ease removal of the sheath from the robotic manipulatorand/or the surgical site, to provide different access or exposure of therobotic manipulator to the surgical site or to expand portions of thecavity as desired to accommodate a particular robotic manipulator. Thecenter wall in various exemplary embodiments may also be reattached tothe side wall by inserting the tab 408 into aperture 403 of side wall409 to further assist in the removal of the manipulator from thesurgical site. Similarly, the side walls may be reattached by insertingtab 406 of side wall 409 into aperture 402 of side wall 407. A tail 404extends proximally from the cover 411 to support the robotic manipulatorand provides a removal or insertion support for the deployment of thesheath 400.

Referring to FIG. 12, the sheath 500 includes a proximal cover 506 and adistal cover 508. The proximal cover includes an elongate portion ortail 504 with arcuate sidewalls 502, 503 that cover portions of arobotic manipulator inserted therethrough. A vertical slit 505 extendsbetween the sidewalls and thus allows the side walls to move away fromeach other. Thus, the proximal cover can expand to accommodate varioussized and shaped robotic manipulators. The proximal cover along with thedistal cover extends the support and conversion of the roboticmanipulator and extends the protection of the robotic manipulator, thepatient and an access platform. As such, the curved sidewalls 502, 503with smooth outer surfaces further assist in the insertion of the sheathinto the body cavity or the access platform by providing a smoothcontinuous interface with minimal friction between the body wall oraccess platform and the sheath. Furthermore, the smooth inner surfacesof the cover do not damage or reduces potential damage to the cover andthe inserted manipulator.

A horizontal slit 507 separates the sidewalls 502,503 of the proximalcover from the distal cover and thereby further allows the proximalcover to expand and the distal cover to separate from the proximalcover. The distal cover includes a proximal opening connecting to acentral lumen or cavity 501 delimited by the proximal cover 506. Thedistal cover 508 also includes a distal opening coupled to the proximalopening of the distal cover and also defines or delimits a cavity orlumen through the distal cover 508. In various exemplary embodiments,the cavity of the distal cover 508 and the cavity of the proximal cover506 are interconnected and in which the robotic manipulator is inserted,seated within and moved there through. In various exemplary embodiments,the distal cover 508 is arranged to swing, pivot or be displaced awayfrom the proximal cover 506 and thereby provides an unobstructed pathwayfrom a proximal opening in the proximal cover to the distal opening inthe proximal cover. The tail 504 surrounded by side walls 502, 503extends from the distal cover 508 to support the robotic manipulator andprovides a removal or insertion support for the deployment of the sheath500.

In various exemplary embodiments, the distal cover 508 is hemisphericalto ease placement of the sheath and in various exemplary embodiments hasa proximal opening but no distal opening to further define the cavity inwhich a robotic manipulator is held, enclosed or encased therein. Assuch, in various exemplary embodiments, the entire distal cover isdisplaceable away from the proximal cover to provide an unobstructedpathway out from the proximal cover.

In FIG. 13, the sheath 600 is a monolithic sheet with ends 607, 609wrapped around each other and defining a cavity or lumen 601. The lumenconnects a proximal opening to a distal opening of the sheath. Theproximal opening has a diameter larger than the diameter of the distalopening. The sheath provides a proximal cover 608 having a frustoconcialshape to facilitate insertion of the sheath. In various exemplaryembodiments, the distal end includes a movable distal wall covering orobstructing the distal opening of the sheath. In various exemplaryembodiments, a tail 604 extends from a portion near the proximal openingof the sheath or along the entire length of the sheath to support therobotic manipulator and provides a removal or insertion support for thedeployment of the sheath. The ends of the sheath at the overlap 606 aremovable relative to each other and thereby allowing expansion of thesheath and thus accommodating various sized and shaped instrumentsinserted therein. Apertures and detents, ratchet like mechanisms or thelike in various exemplary embodiments interconnect the ends 607, 609 ofthe sheath to provide incremental and operational adjustment orenlargement of the cavity 601 of the sheath. As such, the sheath 600extends the support and conversion of a robotic manipulator to auniform, smooth and/or continuous surface or shape and extends theprotection of the robotic manipulator, the patient and an accessplatform.

In FIG. 14, a sheath 700 includes a proximal opening and a distalopening with a central lumen 701 connecting the openings together.Arcuate side sections or walls 707, 709 define the central lumen orcavity in which a robotic manipulator may be inserted into. The sidewalls 707, 709 protect the inserted robotic manipulator. One or moreslits 706 extend from the proximal opening to the distal opening andthereby allows the cover 708 or its side walls to move away from eachother and thus expand thereby accommodating various sized and shapedrobotic manipulator. The cover 708 has a frustoconcial shape tofacilitate insertion of the sheath. In various exemplary embodiments theside walls are biased closed or towards each other and thereby provide aclamping or further fortifying the securement of the sheath to therobotic manipulator. In various exemplary embodiments, the side wallsare attached or incorporated with spring-like material, elastic stripsor fibers or shape memory alloy to bias the side walls or the coverclosed or towards each other. Likewise, the distal and proximal openingsof the sheath can also expand to accommodate various sized and shapedrobotic manipulators being inserted through the sheath. The side walls707, 709 are connected to each other at a distal end and thus expandproximally to distally as needed to accommodate the inserted roboticmanipulator. In various exemplary embodiments, the connection isfrangible or detachable to allow complete separation of the side wallsfrom each other. Additionally, the side walls separated from each othereases removal of the sheath from the surgical site, the surgical roboticmanipulator or both. In the illustrated exemplary embodiment, the sheathdoes not include a flap obstructing the distal opening of the sheath. Invarious exemplary embodiments, portions of the side walls overlap eachother and as such, the side walls overlapping each other cover portionsof the slit. A tail 704 surrounded by side walls 707, 709 and/orextending from the cover 708 supports the robotic manipulator andprovides a removal or insertion support for the deployment of the sheath700. As such, the sheath 700 extends the support and conversion of arobotic manipulator to a uniform, smooth and/or continuous surface orshape and extends the protection of the robotic manipulator, the patientand an access platform.

It should be appreciated that the described features and details of thevarious exemplary embodiments are illustrative and can be applicable tothe other various exemplary embodiments although not explicitly shown ordescribed. Accordingly, combinations of exemplary embodiments andfeatures or aspects of various exemplary embodiments or combinations ofexemplary embodiments described can also be applicable to the otherexemplary embodiments. Any missing described combination or feature isfor clarity or to avoid repetition.

The following remaining description provides features or aspectsapplicable to the various sheath exemplary embodiments and thus thebelow described sheath or sheaths refers to all the sheath exemplaryembodiments, e.g., sheaths 100-700. In various exemplary embodiments,the tail or the elongate portion of the sheath acting or operating as atail may be shorten or have a length equal or less than the length ofthe cover as needed, e.g., where operating space is limited or greaterflexibility or mobility is needed. Similarly, in various exemplaryembodiments the tail of the various sheaths may be removed. In variousexemplary embodiments, the tail is elongate and is longer than the coveras applicable, e.g., where larger coverage or protection of the roboticmanipulator is desired and/or larger removal or insertion area for thedeployment of the sheath is desired. In various exemplary embodiments,the tail extends proximally from the expandable cover and is elongateand planar and is lengthwise longer than the expandable cover. Invarious exemplary embodiments, the tail of the various sheaths includesa curved or raised connector portion connected to the cover. The curvedconnector provides additional lateral or radial space of the roboticmanipulator allowing easier access and attachment of the roboticmanipulator to the sheath and spaces the tail from the roboticmanipulator to further facilitate accessibility of the removal orinsertion area of the tail to assist in deployment of the sheath.

In various exemplary embodiments, the sheath is made of a flexible andcompressible material to conform to the robotic manipulator to affect aninstrument seal due to compressive forces of the body wall or the accessplatform on the sheath. In various exemplary embodiments, the roboticsheath is made of a flexible and compressible material with a lowerdurometer than the surgical robotic manipulator and is arranged toconform to the surgical robotic manipulator due to compressive forces ofthe flexible seal of the surgical robotic access platform arranged tocompress the cavity of the expandable cover of the robotic sheathagainst the distal end of the surgical robotic manipulator and tomaintain an insufflation gas seal between the surgical roboticmanipulator. In various exemplary embodiments, the sheath includes afunnel-shaped cover to provide or ease access of the sheath through thebody wall or access platform.

The various sheaths in various exemplary embodiments include a cover oran expandable portion to accommodate various sized and shaped roboticmanipulators. The sheath covers irregularly shaped, sharp, rough,textured, or other manipulators having undercuts, protrusions, detentsor other similar extremities that may damage the patient and/or accessplatform or create leak paths. As such, the sheath converts irregularshaped robotic manipulators to a more uniform or smooth shape forinsertion, operation and removal without interfering or unduly limitingthe range of operation of the robotic manipulator. The sheath thusprotects the patient, the robotic manipulator and the access platform.

The expandable portion of the sheath in various exemplary embodimentsincludes side walls to protect the outer surface or region of therobotic manipulator. The expandable portion includes an opening thatfacilitates insertion of the robotic manipulator to be seated therein.The distal opening facilitates access of the robotic manipulator throughthe sheath. The side walls also provide a smooth and uniform outersurface to protect the entry point or area into the body or accessplatform. The outer surface also minimizes leak paths or facilitatessealing. The outer surface also facilitates entry and removal of thesheath.

The side walls in various exemplary embodiments define a cavity whereinthe distal end of the robotic manipulator can be seated to secure orattach the sheath to the robotic manipulator. The cavity also providesan area or region in which a distal force applied by the roboticmanipulator is applied or experienced by the sheath. In variousexemplary embodiments, the cavity or lumen of the various sheaths isfilled or lined with foam, inflated bladders or gel cushions to furtherprotect the instrument seated within the cavity. The foam or otherprotective material is lined, affixed or adhered to portions of thecover to ensure the protective material moves away from the path of theinserted instrument or follows movement of the cover while remainingaffixed to the cover to avoid obstructions or debris as the cover orportions thereof are displaced. In various exemplary embodiments, theprotective material is made of a material different from the material ofthe expandable cover and has a lower durometer than the material of theexpandable cover. The various sheaths in various exemplary embodimentsinclude an inner surface that is smooth and uniform to facilitate entry,removal and passage of the robotic manipulator through the sheath. Theinner surface also protects or does not harm the robotic manipulatorinserted therein.

In various exemplary embodiments, the slit or separation between theside walls or the expandable portion of the various sheaths provides anexit region for the sheath to be removed or separated from the roboticmanipulator. In various exemplary embodiments, the sheath is removedfrom the robotic manipulator and in which case the robotic manipulatorremains stationary as the sheath is separated from the instrument. Withthe robotic manipulator remaining stationary, manipulation or placementof the robotic manipulator does not have to be performed or in somecases performed again. As such, operation times or steps can be reducedor avoided. Also, additional space or range of movement for the roboticmanipulator is not required to perform the separation of the sheathwhich can be an issue in the limited confines of the surgical space orthe given access platform.

In various exemplary embodiments the cover of the various sheaths aremade of a spring like material and thus is arranged to return to itsoriginal shape or position and thus provides a clamping or compressionforce upon the inserted robotic manipulator to ensure the cover remainsin place protecting the distal end of the robotic manipulator. Invarious exemplary embodiments, portions of the sheath, e.g., the walls,folds or flaps or the proximal cover and the distal cover, are made ofdifferent materials from each other to accommodate particular roboticmanipulators and their operation. For example, one wall of the sheath ismade of a rigid material to protect a particular portion of the roboticmanipulator requiring enhanced protection and a different wall of thesheath is made of a soft or less rigid material to enhance conformanceof the sheath to the robotic manipulator.

In various exemplary embodiments, the various sheaths are molded into ashape or outline with the outer surface being continuous, uniform andsmooth to ease insertion and placement. The various sheaths include aninner surface forming a cavity or housing for the placement, protection,support and ultimately an entryway for the robotic manipulator. As such,the robotic manipulator and in particular the sharp or irregularlyshaped manipulators can be inserted into a surgical site withoutcompromising the integrity of the access system or patient safety. Invarious exemplary embodiments, the sheath is removed or portions thereofexposing the robotic manipulator for entry into the surgical site.

In various exemplary embodiments, the integrity, shape, dimension oroutline of the cavity of the various sheaths can be maintained and thusdisrupted by or at a single point or area by an attachment or releasemechanism. In various exemplary embodiments, a release line is providedat a release area such that after insertion of the sheath, the releaseline or mechanism is activated remotely or externally from the sheath oroutside the patient to cause the cavity to unfold, separate, tear orbreakaway and thus facilitating removal of the sheath and/or exposing ornot obstructing the robotic manipulator or portions thereof. In variousexemplary embodiments, distal movement of the tail of the sheath causesthe cavity or portions of the sheath to unfold, breakaway, separate ortear and thus allowing quick removal of the sheath and exposure of therobotic manipulator.

In various exemplary embodiments, the portions are held together bycoupling or an interconnection or connector, such as a releasableadhesive, heat bond, mechanical interlocks, magnets or other similarnon-permanent or detachable mechanisms to allow the separation ofportions of the sheath as desired. The connection or interlocks mayinclude notches, tabs, detents or other similar defects on portions orends of the cover to create or increase the mechanical interlock of thecover ends. Ball and socket, opposing hooks, ratchets, spring pins, orother connector configurations may also be provided to lock or connectportions of the sheath together. Alternatively, in various exemplaryembodiments, the portions of the sheath, e.g., cover ends or walls, maybe left uncoupled or separated and not connected. In various exemplaryembodiments, the coupling, connector or interconnection of the portionsof the sheath provides a one-way incremental and operational adjustmentof the portions of the sheath, e.g., the cover, lumen or cavity, thatonce adjusted or manipulated, the coupling or connector is unable to bereattached or readjusted, e.g., once enlarged is unable to becontracted.

In various exemplary embodiments, the coupling, connector orinterconnection of portions of the sheath is used to temporarilymaintain a specified sheath shape or size. In various exemplaryembodiments, releasing, disengaging or removing the coupling, e.g., bypulling a cord or manipulating a release actuator connected to thecoupling, connector or interconnection, after insertion of the sheathwould unfold or deploy the sheath or portions thereof to therebyfacilitate removal of the sheath, access for the robotic manipulator,enlargement of the cavity or any combination thereof. In variousembodiments, the disengagement may be incremental, one-way or both. Invarious exemplary embodiments, moving or pulling the tail or proximalend of the sheath proximally would unfold or deploy the sheath such astearing or disengaging the interconnection between the sides or folds ofthe sheath. In various exemplary embodiments, the sheath may include oneor more folds, walls or flaps that may be folded, formed orinterconnected into a desired shape and dimension to accommodate therobotic manipulator or surgical site. In various exemplary embodiments,the size and shape of the spacing or slits between the folds, walls orflaps may be formed or temporarily connected into a desired shape anddimension to accommodate the robotic manipulator or surgical site. Invarious exemplary embodiments, the sheath may include a proximal cover,a distal cover or both with different sizes and shapes and defining ordelimiting similar or different sizes and shapes of cavities or lumensto accommodate a particular robotic manipulator. In various exemplaryembodiments, the sheath may include a proximal cover, a distal cover orboth with similar sizes and shapes and defining or delimiting similar ordifferent sizes and shapes of cavities or lumens to accommodate aparticular robotic manipulator.

Additionally, with the sheath being inserted into the access platform orthrough the body wall, the center wall, fold, flap and/or cover isbiased proximally by the access platform or body wall contacting thefold, wall, flap and/or cover thereby also counteracting any forces bythe robotic manipulator being inserted, enclosing the cavity andencasing and protecting the inserted robotic manipulator.

In various exemplary embodiments, the robotic manipulator is moved toseparate the sheath from the robotic manipulator. With the roboticmanipulator causing the separation, a separate actuator or similarengagement portion can be avoided. In particular, a separate actuator isnot required to access the tail of the sheath to remove the sheath oncethe instrument is placed at the surgical site.

The different or varied robotic sheaths may be used for or to identifydifferent robotic manipulators or other identifying indicia of therobotic manipulator operation, surgical robotic system or surgicalprocedure. In various exemplary embodiments, the sheath is made frommolded silicone, rolled plastic shim material, folded films or anycombination thereof. In various exemplary embodiments, the sheath iscost effective and can be single-use disposable for each access orplacement of the sheath. In various exemplary embodiments, the slits orspacing or distance between the folds, walls or flaps are constant orcontinuous. In various exemplary embodiments, the distance between thefolds, walls or flaps is between 2 to 4 millimeters.

Referring now also to FIGS. 15-29, in various exemplary embodiments, asurgical robotic access system comprises a surgical access platform. Thesurgical access platform comprises a flexible seal 804 that sealinglyconforms or engages with the robotic manipulators and/or the sheathwhile maintaining pneumoperitoneum during insertion, operation andremoval. The flexible seal in various exemplary embodiments iscontained, integrated or attached to a cap ring or cover 808 to form asealing cap 800.

The sealing cap 800 in various exemplary embodiments is incorporatedwith or removably attached to a retractor or protector 820 that providesretraction and/or protection of the incision or opening in the patient.In various exemplary embodiments, the retractor includes a sleeve ortube 816 extending between an inner ring 815 placed inside the patientand an outer ring 817 placed outside the patient. Both rings can berigid, flexible or any combination thereof. The sleeve is flexible andcylindrical. In various exemplary embodiments, the sleeve has anothershape, such as an oval or a more complex shape, is adjustable, istransparent or any combinations thereof. In various exemplaryembodiments, the length of the sleeve is adjustable by varying thelocation of the outer and inner rings or by gathering or windingportions of the sleeve around the outer ring, the inner ring, anadaptor, another ring or the like and any combination thereof. Invarious exemplary embodiments, the sleeve is non-adjustable defining afixed length and diameter access channel. In various exemplaryembodiments, the sleeve includes one or more coatings such as alubricious coating, anti-microbial coating or both. Examples of sealingcaps, retractors and/or protectors are described in U.S. PatentPublication No. 2007/0088204 A1, the disclosure of which of incorporatedby reference as if set forth in full herein. Examples of a flexible sealor material including gel material are described in U.S. patentapplication Ser. No. 10/381,220, filed Mar. 20, 2003, the disclosure ofwhich is hereby incorporated by reference as if set forth in fullherein.

In various exemplary embodiments, the sealing cap covers the proximal orouter portion of the retractor/protector. In various exemplaryembodiments, the sealing cap provides additional access areas orportions. In the illustrated exemplary embodiment, the sealing capincludes a flexible seal or cover made of a flexible material, e.g., gelmaterial, surrounding the sheath and through which robotic manipulatorsmay be inserted directly there through for additional access into thepatient. In various exemplary embodiments, auxiliary surgicalinstruments are insertable directly through the flexible seal inportions around or adjacent the sheath. The flexible seal provides aseal around or sealingly engages an outer surface of the auxiliarysurgical instruments as the instruments are inserted, utilized orwithdrawn from the flexible seal around the sheath and provides a sealin various exemplary embodiments in the absence of a surgical instrumentinserted in the flexible seal around the sheath.

The retractor/protector 820 provides a stable platform to connect thesealing cap 800 to the patient. The stable platform allows movement ofthe sheath within the flexible seal while minimizing any additionalmovement or forces caused by movement of the sheath on the flexibleseal. As such, the outer portion of the flexible seal, the ring or bothreduces or dissociates movement of the flexible seal caused by thesheath relative to the rest of the sealing cap and the patient. Also,the retractor/protector attached to the sealing cap further dissociatesmovement of the sealing cap on the patient caused by movement of theflexible seal of the sealing cap. The retractor/protector alsoatraumatically retracts the opening in the patient to increase range ofaccess or mobility of the robotic manipulators and positions the tissue,around and through the opening, away from potential contact or traumafrom the inserted surgical robotic manipulators.

In various exemplary embodiments, an instrument shield or retractorshield is disposed between the sealing cap and the retractor to preventor reduce potential damage to the retractor or protector and/or todirect off-axis manipulators towards the center or opening in thepatient. In various exemplary embodiments, the sealing cap may beconnected directly to the patient via sutures or adhesive and may beprovided with or without the retractor, shield or both.

In various exemplary embodiments, the sheath is removably insertableinto the sealing cap and, in various exemplary embodiments, a raisedportion of the flexible seal surrounds a cavity to further secure orreinforce the engagement of the sheath with the flexible seal. Invarious exemplary embodiments, the flexible seal has a uniform height orthickness throughout the seal. In various exemplary embodiments, theflexible seal has a center cavity disposed within the cavity to furtherassist in the insertion of a manipulator and sealing against themanipulator or in the absence of the manipulator. As such, the centercavity provides another reduced layer of thickness or increasedflexibility relative to the surrounding cavity and the surroundingflexible seal, e.g., the material within the cavity or between thecavity and the edge or outer periphery of the sealing cap.

In various exemplary embodiments, the flexible seal within and/or belowthe sheath provides a seal for a surgical robotic manipulator to beinserted there through or in the absence of a manipulator insertedthrough the flexible seal. The reduced portion of the flexible sealdefined and/or confined by the sheath provides a consistent density orconsistency to provide a predefined or pre-known or predictableinsertion force that may be used to generate haptic feedback or othersimilar sensor information to be recognized by the surgical roboticssystem to identify and/or simulate the insertion and withdrawal of thesurgical robotic manipulator.

In various exemplary embodiments, the sealing cap includes a flexibleseal being resilient to doming during insufflation and to the insertionand removal of irregularly shaped or sharp robotic manipulators.Anti-doming of the flexible seal of the sealing cap in various exemplaryembodiments comprises a mesh or a mesh lined pattern molded into theflexible seal that limits the amount of movement along a central axis ofthe sealing cap while still providing freedom for the flexible seal toseal around a robotic manipulator. In various exemplary embodiments, asshown for example in FIGS. 17-18, a line 809, e.g., a monofilament line,is cast or molded into the flexible seal in a star or web pattern toreduce doming of the flexible seal during pneumoperitoneum. In variousexemplary embodiments, the line is weaved through the apertures or holesin the cap ring 808 to form a pattern to support and/or reinforce theflexible seal under pneumoperitoneum. In various exemplary embodiments,In various exemplary embodiments, the line is weaved into a pattern withthe middle of the pattern being clear of the line. In various exemplaryembodiments, the ends of the line are tied in a knot and/or adhered andloosely weaved to prevent deformation of cap ring during pre-molding.The anti-doming of the flexible seal prevents or reduces undesiredmovement of the area of the flexible seal or the sheath within theflexible seal that is sealing around the robotic manipulator and/or therobotic manipulator sealingly engaging the flexible seal. In variousexemplary embodiments, the monofilament line is molded into the flexibleseal and weaved through apertures in the cap ring in a pattern with themiddle of the pattern being clear of the line. In various exemplaryembodiments, the monofilament line being made of a material differentfrom the flexible material of the flexible seal and has a thicknesssmaller than the thickness of the flexible material

In various exemplary embodiments, the sealing cap includes a flexibleseal fortified to resist puncture or damage from irregularly shaped orsharp robotic manipulators. In various exemplary embodiments, theflexible seal includes one or more shields or protectors, e.g., sheetsof puncture resistant film, fabric or the like, within or attached tothe flexible seal and/or augmenting a specific access point or areathrough the flexible seal such as an opening or slit. The one or moreshields also help to deflect off-axis robotic manipulators intoalignment or towards the center or midline of the patient opening or theflexible seal as the robotic manipulator is inserted or passes throughthe flexible seal.

In various exemplary embodiments, the one or more shields are embeddedin the flexible seal and are arranged inside the inner periphery of thesealing cap. In various exemplary embodiments, the protectors arepositioned between the inner and outer surface of the flexible seal. Theprotectors are confined within a particular area or space of theflexible seal to allow additional access through the surroundingflexible seal as well as to allow freedom of movement of the flexibleseal unencumbered or obstructed by the protectors. The flexible seal inone exemplary embodiment is made of a gel material and in variousexemplary embodiments an upper surface of the shields and a lower and/orside surfaces of the shields are surrounded by or directly attached andembedded in the flexible seal.

In various exemplary embodiments, as shown for example in FIGS. 15-18, asurgical robotic access system is provided in which a sealing capincludes protectors or shield leaves 801, 803 to protect the flexibleseal 804, the robotic sheath, the robotic manipulator or any combinationthereof. The shield leaves 801, 803 are embedded in the flexible seal804 that is attached to or integrated into a ring, cap or cover 808. Byembedding the shield leaves in the flexible seal, any forces that maydislodge the shield is eliminated or greatly reduced. In variousexemplary embodiments, the shield leaves 801, 803 are a pair ofrectangular fabric or film sheets covering a center region of theflexible seal. In various exemplary embodiments, the film or fabricsheets are one by three inch strips. In various exemplary embodiments,the shield leaves have a plurality of openings along their edges or endsassisting in the attachment and securement of the shield leaves to theflexible seal. In various exemplary embodiments, the shield leaves haveor define a central opening with the edges of the shield leaves embeddedinto the flexible seal. In various exemplary embodiments, the shieldleaves are made of a material different from the flexible material ofthe flexible seal and have a higher durometer than the flexible materialand/or have a higher leak rate than the flexible material in presenceand absence of an instrument inserted therethrough. The shield leaves invarious exemplary embodiments are embedded in the flexible seal byattaching to the leaves to a metallic shim. The metallic shim holds thearrangement or placement of the shield leaves to be molded or embeddedinto the flexible seal. The metallic shim also spaces or separates theleaves to provide a space or opening between the leaves during themolding or embedding of the leaves into the flexible seal. Once formed,the metallic shim can be removed from the flexible seal.

Additionally, a filament or line, as previously described, may also beweaved through the cap ring to form a pattern to further support theflexible seal and the shield and to reduce doming of flexible sealduring pneumoperitoneum. As such, the line is cast or molded along withthe shield leaves into the flexible seal. In various exemplaryembodiments, the leaves are disposed in the middle of the flexible sealto shield an inner layer of a slit, opening or an x-slit within theflexible seal. In various exemplary embodiments, the slit or x-slit iscreated using sheet metal glued together in a specific orientationproviding a taper such that device tips will be funneled towards thecenter of the slit and protect the flexible seal from puncturing. Invarious exemplary embodiments, the middle portions of film strips orsheets are glued to x-slit shims to hold the sheets in place whileflexible material of the flexible seal is being cured or molded. Invarious exemplary embodiments, the shield sheets or film has a lowfriction or non-tacky side to ease manufacturing and operationalmovement of the shield and a fabric side to provide additionalprotection to the sheets, the flexible seal, or an opening through theflexible seal or to provide a predefined target area. In variousexemplary embodiments, the low friction side is face down in the mold,which faces up proximally or towards a surgeon in operation and thefabric side adheres to the flexible seal and keeps the shield in placein the flexible seal. In various exemplary embodiments, the low frictionside is coated or otherwise formed or arranged to remain separate fromflexible material of the flexible seal. In various exemplaryembodiments, the inserted robotic manipulator or sheath contacts the lowfriction side of shield and the shield prevents the inserted manipulatoror sheath from digging into the flexible material of the flexible seal.

In various exemplary embodiments, the flexible material, e.g., a gelmaterial, is poured into a mold to hold x-slit shim in place and preventair from being trapped under a sheet. Also, the x-slit shim prevents theshield leaves from resting against the mold as the gel material is beingcured to ensure the gel material is between the mold and the shieldleaves. As such, the leaves remain within gel material or under theouter surface of the gel material and a hole or opening for the gas(e.g., carbon dioxide) to escape is avoided. After curing, e.g.,removing heat and cooling, the x-slit shims are removed while the shieldleaves remain within the flexible material. In various exemplaryembodiments, the shield leaves are disposed to augment or reinforce theopening or x-slit in the flexible seal.

In various exemplary embodiments, an opening actuator, e.g., one or morehandles and lines 811, cord, string or the like are attached to one ormore of the shield leaves, e.g., shield leaf 803. Manipulation of theopening actuator opens or closes the shield leaves by adjusting theseparation or space between the shield leaves. For example, moving orpulling the line proximally and/or laterally loosens or increasesseparation, distance or spacing between the shield leaves and/or theportions of the flexible material surrounding or adjacent to the shieldto thereby ease placement of robotic manipulator. Similarly, releasingor not manipulating the line allows the shield and/or flexible seal toremain or return to their initial state and thus apply radial orcompression force or circumferential pressure and provide sealingengagement with the robotic manipulator or sheath in place or fortifyportions of the flexible seal, e.g., around a central opening in theflexible seal.

In various exemplary embodiments, the shield may be of varied shapes,sizes and number. For example, as shown in FIG. 19, scalloped shields ortear dropped shaped seals 812 are arrayed covering a center region ofthe flexible seal. The flexible seal surrounding the scalloped shields812 remains unobstructed. As shown, the shields and/or flexible seal mayinclude indicia or other indicators to highlight a portion of theflexible seal, the shield and/or sealing cap to direct or provide atarget area for the sheath and/or robotic manipulator to be insertedtherethrough.

In various exemplary embodiments, the scalloped shields so arranged canflex or move distally and assist in moving the flexible seal from thepathway of the inserted sheath or robotic manipulator to guide thesheath or manipulator and partially or fully protect the flexible seal.The scalloped shields are arranged or interconnected with each othersuch that movement of one of the shields effects movement of thesurrounding shields to further guide and facilitate entry of the sheathor robotic manipulators through the flexible seal.

In various exemplary embodiments, the flexible seal, as shown in FIGS.20-21, includes a shield 814, e.g., a single piece or monolithic shield,to guide robotic manipulators or sheaths through the access platform andprovide further protection for the sheath, flexible seal or accessplatform. The shield includes holes or apertures along its edges or endsto enhance securement of shield to the flexible seal. In variousexemplary embodiments, the shield 814 is a curved or angled plastic orfabric sheet. The shield includes angled side walls 821, each identicaland mirror images of each other that meet together at their edge and invarious exemplary embodiments over a midline of flexible seal or abovethe slit. Top and bottom angled walls 822 fill in top or bottom portionsof the shield to direct the shield and an inserted sheath or manipulatortowards the middle or center edge of the side walls. In variousexemplary embodiments, tabs or flanges 823, 824 extend from the sidewalls, the top wall and/or bottom wall and in various exemplaryembodiments include holes or apertures 825, 826 to further fortify,embed or secure attachment of the shield to the flexible seal.

In various exemplary embodiments, the shields or protectors have oneedge elevated above an edge at the midline of the flexible seal toprovide a tapered or sloped shielded entry to facilitate movement of theprotectors and to direct the inserted robotic manipulator towards theslit in the flexible seal. In various exemplary embodiments, theflexible seal or material directly under the protectors arecorrespondingly shaped and sized to accommodate the shape and size ofthe protectors. The shields in various exemplary embodiments are castinto the flexible seal to protect or reinforce the flexible seal ormaterial from being torn or punctured by the tips of the surgicalrobotic manipulators in such a way to effectively disrupt or makeineffective the zero sealing or instrument sealing capabilities of thesealing cap. In various exemplary embodiments, the shields are made outof a soft and durable material to provide a lubricious surface for thetips of the robot manipulators to ride against during insertion orwithdrawal of the robot actuators. In various exemplary embodiments, theshield is made from a material different, more durable and rigid or anycombination thereof than the material of the flexible seal. In variousexemplary embodiments, the shield, shields or protectors are made of amaterial different from the flexible material of the flexible seal andhave a higher durometer than the flexible material and/or have a higherleak rate than the flexible material in presence and absence of aninstrument inserted therethrough. In various exemplary embodiments, oneor more opening actuators, e.g., one or more handles and/or lines, cord,string or the like, are attached to one or more shields or portions ofthe shield to adjust, e.g., increase or decrease, the separation ordistance between the one or more shields or portions of the shieldcorresponding with movement of the one or more opening actuators.

In various exemplary embodiments, a double duckbill seal is cast intothe flexible seal to provide an additional or separate zero seal or sealin absence of a surgical robotic manipulator. The duckbill seal invarious exemplary embodiments is made of a material different from thematerial of the flexible seal. The duckbill seal is compressible by thesurrounding flexible seal to further enhance the seal of the duckbillseal. In various exemplary embodiments, the duckbill seal does notextend through the flexible seal and instead is completely embedded inthe flexible seal to further enhance the seal of the sealing cap and theduckbill seal. The protector or shields in various exemplary embodimentsmay be included and precede the duckbill seal.

In various exemplary embodiments an insufflation port 806, an evacuationport 805 or both are disposed through the ring 808, the flexible seal804 or both to access the body cavity. As such, gas or fluid such asinsufflation gas can be externally supplied via an inlet of theinsufflation port 806 from a gas source outside or external to thepatient and the robotic access system. The externally supplied gas isintroduced into the patient through an outlet of the insufflation portwhile the flexible seal prevents any gas or fluid from escaping.Similarly, gas or fluid such as smoke may be extracted from within thepatient through the inlet of the evacuation port 805 and pulled outexternally through an outlet of the evacuation port into an appropriatecanister, suction or evacuation system to properly dispose of thepotentially harmful or disruptive gas or fluid.

In various exemplary embodiments, an outer portion of the flexible sealis coupled to the ring 808 and in one exemplary embodiment is molded toa plurality of apertures disposed along the periphery of the ring. Invarious exemplary embodiments, the ring 808 of the sealing cap includesa pivotably coupled latch 807 along with a stationary ledge or flange810 assisting in removably coupling the sealing cap to the protector. Invarious exemplary embodiments, the ring and flexible seal are made ofthe same material and thus together form a monolithic structure. Invarious exemplary embodiments, as shown for example in FIGS. 22-23, theflexible seal 804 includes one or more zero seals 901, 902, 903 such asa duckbill or flapper seal attached to or integrated into the flexibleseal in absence of a trocar, sheath or the like not inserted into theflexible seal. In various exemplary embodiments, one or more septum orinstruments seal are integrated or included with one or more zero sealto further sealingly engage with an outer surface of inserted sheathand/or manipulator. The zero seals, instrument seals or both provideadditional target areas for the sheaths and/or robotic manipulators andmay be provided with reduced thickness or stiffness to ease insertion ofan inserted robotic manipulator and sealing of the flexible seal whenthe robotic manipulator is withdrawn. In various exemplary embodiments,the zero seals 901, 902, 903 and flexible seal 804 are molded as asingle monolithic structure and thus are made of the same material.

As shown in FIGS. 24-27, the flexible seal 804 in various exemplaryembodiments includes a plurality of apertures. Two of the apertures1111, 1113 include an elastomeric cylindrical laterally extendingbellows that are used to both attach and sealingly engage a trocar orsheath to the flexible seal 804. The surrounding material of theflexible seal 804 is less resilient or stiffer than the bellowssurrounding or attached to the apertures of the flexible seal. As such,the surgeon is provided a pronounced degree of movement for the attachedtrocar or sheath. In various exemplary embodiments, the flexible sealhas a central aperture 1112 that is larger than the other apertures. Invarious exemplary embodiments, each or some of apertures include or havea zero seal such as duckbills 1121, 1122 or flapper seal 1123 attachedto or integrated into the respective aperture to provide a seal inabsence of a trocar, sheath or the like not inserted into the apertures.In various exemplary embodiments, one or more septum or instrumentsseals are integrated or included with one or more zero seals to furthersealingly engage with an outer surface of an inserted sheath and/ormanipulator. In various exemplary embodiments, removable access ports1116, 1118 of varied diameter size are provided for auxiliary surgicalinstruments or surgical robotic manipulators and are inserted into theapertures 1111, 1112, 1113 and/or around a sheath or central aperture1112. In various exemplary embodiments, the removable access portscomprise of a cannula with an attached or integrated seal assembly withan instrument seal, zero seal or both. The cannula in various exemplaryembodiments has one or more support structures on the outer surface ofthe cannula to removably secure the removable access port to theflexible seal. In various exemplary embodiments the removable accessports are all utilized to increase triangulation manipulation or viewingfor the surgical procedure and may include additional inlets/outlets forinsufflation and/or evacuation.

In various exemplary embodiments, the surgical robotic access systemprovides access into a patient's body cavity for a 22mm diametersurgical robotic manipulator and/or a sheath. The surgical roboticaccess system provides a seal, e.g., a zero seal, when the roboticmanipulator and/or sheath are not inserted through the robotic accesssystem. The surgical robotic access system also provides an instrumentseal when the robotic manipulator is inserted through the robotic accesssystem. The seal prevents the loss or escape of fluids or gases used orencountered in a surgical procedure. The surgical robotic access systemin various exemplary embodiments also provides access for introducing orremoving of gas or fluids such as insufflation gas, smoke or the like.The surgical robotic access system provides protection for and fromdistal tips of the robotic manipulator from damaging the surgicalrobotic access system, the patient and the robotic manipulator.

In various exemplary embodiments, a surgical robotic access systemprovides a seal arrangement for a surgical robotic manipulator to beinserted there through or in the absence of a manipulator. In accordancewith various exemplary embodiments, as shown in FIG. 28, the sheath 300may be introduced through a body wall and into a patient's body cavitythrough an incision or opening in the patient. Similarly, as shown forexample in FIGS. 29-30, the sheath in accordance with various exemplaryembodiments may be introduced through an access platform. (Althoughsheath 300 is shown in FIGS. 28-30, other various sheath exemplaryembodiments (e.g., sheaths 100-700) described throughout the applicationmay be similarly used.) Likewise, although a particular surgical accessplatform and/or sealing cap is shown, other surgical access platformexemplary embodiments and features thereof described throughout thedisclosure may be similarly utilized. Prior to introduction into thepatient, the sheath has expanded or contracted to accommodate andsupport the robotic manipulator and otherwise converted an irregularlyshaped robotic manipulator to a uniform and smooth form for entry intothe patient's body. After insertion into the body cavity via anincision, opening and/or a surgical access platform, the roboticmanipulator may be extended distally tearing, unfolding or exiting fromthe distal end of the sheath to perform its intended surgical function.In various exemplary embodiments, prior to the sheath being introducedinto the patient and/or the surgical access platform, the patient's bodycavity is not insufflated and after insertion, the patient's body cavityis insufflated. Alternatively or additionally, the sheath may beretracted or pulled back proximally to expose or cause the roboticmanipulator to exit the sheath thereby allowing the robotic manipulatorto perform its intended surgical function unimpeded. After use, therobotic manipulator may be retracted proximally and/or the sheath may bemoved distally to again cover or encase the robotic manipulator withinthe sheath. As such, the sheath and the robotic manipulator may beremoved or withdrawn together from the patient's body and/or surgicalsite. In various exemplary embodiments, the sheath may be completelyremoved from the surgical site before or after withdrawal of the roboticmanipulator from the patient's body or surgical site. In variousexemplary embodiments, a frangible collar 302 is disengaged or torn todetach the sheath from the robotic manipulator.

In accordance with various exemplary embodiments, the dashed lines 24represent the protector and its film that may be twisted prior to itsinsertion into or within the opening in the patient. The film twistedcan further assist in sealing the opening of the patient. In variousexemplary embodiments, the dashed lines 16 represent the body wall andthe sleeve of the retractor retracting the opening in the patient toease access into the patient. In the illustrated exemplary embodiments,one or more of the components are shown transparent or translucent tobetter show some of the underlying components or features otherwisehidden by the flexible seal or sealing cap. In various exemplaryembodiments, the dashed line 18 outlines or provides a differentconsistency or flexibility of the flexible seal relative to thesurrounding material and in various exemplary embodiments the flexibleseal within the dashed line 18 is firm or more rigid relative to thesurrounding material and thus moves or translates freely relative to thering while the sheath remains static relative to the flexible sealimmediately surrounding the sheath. The dashed lines 3, 5 generallyrepresent the upper and lower surfaces of the body wall of a patient.Additionally, in various exemplary embodiments and operations, thepatient's body cavity is insufflated or under pressure. The dashed line7 represents the mid-line or longitudinal axis of the surgical roboticaccess system and in various exemplary embodiments represents an initialincision or opening in the patient.

In the illustrated exemplary embodiments, it is exemplified that thesurgical robotic access system, e.g., the sealing cap and the sheath,may have different sizes, shapes and dimensions. The dimensions, shapesand sizes may be dictated or determined based on the surgical proceduresor the surgical robotic system. The sheath, for example, although shownas generally frustoconical, tubular or cylindrical may be of variedshapes and dimensions such as an hour-glass or the like to optimize thesurgical site space or sealing engagement with surgical roboticmanipulator or the sealing cap. Similarly, the materials of the surgicalrobotic access system may vary to optimize the surgical site space orconnectivity to the surgical robotic system. In various exemplaryembodiments, the sheath is made of a flexible and compressible materialor made of a lower durometer than the flexible material to conform tothe robotic manipulator to affect an instrument seal due to compressiveforces of the body wall or the access platform, e.g., the flexible seal,on the sheath. In various embodiments, the robotic sheath is rigid or ismade of a material with a higher durometer than the flexible material ofthe access platform in that the material of the robotic sheath isarranged to resist compressive forces of the flexible material therebyprotecting the surgical robotic manipulator and yet maintaining aninsufflation gas seal between the robotic sheath and the flexiblematerial.

Throughout a surgical procedure, the surgical robotic manipulator may beinterchanged with other surgical robotic manipulators each havingdiffering or varying geometry and/or dimensions. The roboticmanipulator, e.g., exemplary robotic instrument 11, is roboticallycontrolled autonomously or through assistance of a surgeon without asurgeon in direct contact or physically grasping the surgical roboticmanipulator. The distal ends of the surgical robotic manipulator invarious exemplary embodiments are removable and hot swappable with otherdistal ends of the surgical robotic manipulator that are arranged topreform specific surgical functions, such as stapling, electro-cautery,grasping, viewing, cutting and the like. In various exemplaryembodiments, the robotic manipulator is surrounded by a robotic drape orsleeve integrated with or included with the surgical robotic system butis separate and distinct from the sheath. In various exemplaryembodiments, both the robotic sleeve and the robotic manipulators arerobotically controlled. The robotic sleeve in various exemplaryembodiments includes a flexible robotic housing or tube and collarthrough which a surgical robotic manipulator can be maneuvered therethrough and into a patient's body. The robotic sleeve like the surgicalrobotic manipulator is similarly attached or included with the sheath inaccordance with various exemplary embodiments described throughout theapplication.

The surgical robotic manipulators can vary in shape and sizes and thusthe sheath, sealing cap or combinations thereof in various exemplaryembodiments provides an adaptable yet static sealing arrangement to sealagainst the varied shapes and sizes of the surgical robotic manipulatorsor in the absence of a surgical robotic manipulator. The sheath, sealingcap or combinations thereof also does not damage or disrupt the surgicalrobotic manipulator. The sheath, sealing cap or combinations thereofalso facilitates the seal with the opening in the body and allowsfreedom of movement of a robotic manipulator which facilitates the sealwith or to a robotic sleeve and/or manipulator and reduces potentialdamage to the robotic sleeve and/or manipulator due to off axismovements. In various exemplary embodiments, the sheath, sealing cap orcombinations thereof also facilitates a seal with the opening in thebody and the sealing cap allows freedom of movement of a sheath whichfacilitates the seal with or to a robotic sleeve and/or manipulator andreduces potential damage to a robotic sleeve and/or manipulator due tooff axis movements.

The above description is provided to enable any person skilled in theart to make and use the surgical robotic access system described hereinand sets forth the best modes contemplated by the inventors of carryingout their inventions. Various modifications, however, will remainapparent to those skilled in the art. It is contemplated that thesemodifications are within the scope of the present disclosure. Differentexemplary embodiments or aspects of such exemplary embodiments may beshown in various figures and described throughout the specification.However, it should be noted that although shown or described separatelyeach exemplary embodiment and aspects thereof may be combined with oneor more of the other exemplary embodiments and aspects thereof unlessexpressly stated otherwise. It is merely for easing readability of thespecification that each combination is not expressly set forth. It istherefore also to be understood that the system or devices may bepracticed otherwise than specifically described, including variouschanges in the size, shape and materials. Thus, exemplary embodimentsdescribed should be considered in all respects as illustrative and notrestrictive.

1. A surgical robotic access system providing instrument access into apatient's body, the surgical robotic access system comprising: asurgical robotic access platform having a proximal portion disposedexternally to a patient's body and a distal portion positioned within apatient's body, the proximal portion of the surgical robotic accessplatform including a flexible seal; and a robotic sheath having aproximal end and a distal end insertable through the flexible seal ofthe surgical robotic access platform, the robotic sheath having anexpandable cover disposed at the distal end of the robotic sheath anddefining a cavity having a proximal opening and a distal opening andthrough which a surgical robotic manipulator is insertable therethrough;wherein the expandable cover comprises a plurality of folds and one ormore release lines, wherein the plurality of folds are removablyconnected to each other via the one or more release lines, and whereinproximal movement of the one or more release lines disengages orseparates one or more of the plurality of folds from being connected toeach other.
 2. The system of claim 1 wherein the expandable cover of therobotic sheath is arranged to encase and surround a distal end of thesurgical robotic manipulator within the cavity of the robotic sheath andthe flexible seal is arranged to encase and surround the expandablecover of the robotic sheath to compress the expandable cover of therobotic sheath against the distal end of the surgical roboticmanipulator and thereby maintain an insufflation gas seal between therobotic sheath and the flexible seal.
 3. The system of claim 1 whereinat least one of the one or more release lines are configured toremovably connect each of the plurality of folds together, and whereinthe proximal movement of the at least one release line causes theplurality of folds to separate from each other thereby allowing at leastone of the plurality of folds to unfold distally under pressure of therobotic manipulator being moved distally towards the distal opening ofthe cavity defined by the expandable cover of the robotic sheath.
 4. Thesystem of claim 3 further comprising a perforation in one or more of theplurality of folds, wherein the perforation is located at a connectionarea where one or more of the plurality of folds is removably connectedto the one or more release lines, and wherein the proximal movement ofthe one or more release lines separates portions of the plurality offolds along the perforation to releasably disengage the release linefrom the plurality of folds.
 5. The system of claim 1 wherein the one ormore release lines comprises a first release line that is removablyattached to a first subset of the plurality of folds and a secondrelease line that is removably attached to a second subset of theplurality of folds thereby allowing selective movement of one or more ofthe plurality of folds relative to each other.
 6. The system of claim 1wherein the expandable cover includes an exterior surface and aninterior surface, both surfaces being uniform and smooth and wherein theinterior surface of the expandable cover is lined with a protectivematerial affixed to the interior surface, the protective material beinga material different from a material of the expandable cover and havinga lower durometer than the material of the expandable cover.
 7. Thesystem of claim 1 wherein the flexible seal further comprises a shield,the shield located at a center of the flexible seal and embedded withinthe flexible seal, wherein the shield has a plurality of openings alongan edge of the shield embedded within the flexible seal, the shieldbeing made of a material that is: different from a flexible material ofthe flexible seal, has a higher durometer than the flexible material ofthe flexible seal, and has a higher leak rate than the flexible materialof the flexible seal in presence and absence of an instrument insertedtherethrough.
 8. The system of claim 7 further comprising one or moreactuators attached to at least one shield portion of the shield toadjust a distance between two or more shield portions with movement ofat least one of the one or more actuators.
 9. The system of claim 1wherein the cavity of the expandable cover of the robotic sheath isarranged to expand upon insertion of the surgical robotic manipulatorinto the cavity and the flexible seal is arranged to encase and surroundthe expandable cover of the robotic sheath, the robotic sheath beingmade of a material with a lower durometer than the surgical roboticmanipulator and being arranged to conform to the surgical roboticmanipulator due to compressive forces of the flexible seal of thesurgical robotic access platform arranged to compress the cavity of theexpandable cover of the robotic sheath against the distal end of thesurgical robotic manipulator and to maintain an insufflation gas sealbetween the surgical robotic manipulator, the robotic sheath and theflexible seal and wherein a distal most end of the robotic sheath isoperationally disposed beneath a lower surface of the flexible seal andthe proximal portion of the robotic sheath and the flexible seal areoperationally disposed outside of the patient's body, the proximalportion of the robotic sheath having a retrieval tail proximallyextending from the expandable cover of the robotic sheath and therobotic sheath being removable from the surgical robotic manipulatorwith a distal portion of the surgical robotic manipulator being disposedthrough the flexible seal of the surgical access platform.
 10. Thesystem of claim 1, wherein the plurality of folds comprises a first foldand a second fold that are configured to cover sides of the surgicalrobotic manipulator inserted within the robotic sheath.
 11. The systemof claim 1, wherein the plurality of folds comprises a middle foldconfigured to cover the distal end of the robotic sheath.
 12. The systemof claim 7, wherein the shield of the flexible seal comprises aplurality of portions that are identical and mirror images with respectto each other, and wherein a pair of shield portions of the plurality ofportions meet together at their respective edge over a midline of theflexible seal.
 13. The system of claim 7, wherein the shield of theflexible seal comprises one or more shield portions that have anelevated edge above a midline of the flexible seal to provide a taperedor sloped shielded entry that facilitates movement of the surgicalrobotic manipulator towards a middle of the flexible seal.
 14. Thesystem of claim 7, wherein the shield further comprises holes orapertures that further fortify, embed, or secure the shield to theflexible seal.
 15. The system of claim 7, wherein the shield of theflexible seal comprises a lubricious surface to facilitate insertion orwithdrawal of the surgical robotic manipulator through the flexibleseal.
 16. The system of claim 8, wherein the one or more actuators usedto adjust the distance between the two or more shield portions compriseone or more of handles, lines, cords, or strings.
 17. The system ofclaim 1, wherein: the plurality of folds comprises a first fold and asecond fold configured to cover sides of the surgical roboticmanipulator and a third fold configured to cover the distal end of therobotic sheath, and at least one release line of the one or more releaselines removably connects the third fold to both the first fold and thesecond fold, and wherein the proximal movement of the one release linedisengages or separates the third fold from both the first fold and thesecond fold while the first and second folds remain connected.
 18. Thesystem of claim 17, wherein additional movement of the at least onerelease line, after the third fold has been disengaged or separated fromthe first fold and the second fold, is configured to regulate movementof the third fold with respect to the distal opening of the cavitydefined by the expandable cover of the robotic sheath.
 19. The system ofclaim 1, wherein the plurality of folds comprises a first fold and asecond fold configured to cover sides of the surgical roboticmanipulator and a third fold configured to cover the distal end of therobotic sheath, and at least one release line of the one or more releaselines removably connects the first, second and third folds together, andwherein the proximal movement of the one release line disengages orseparates each of the first, second, and third fold from each other.